Study Complete
Sponsor ID
20130240

Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in FrancePILOTE

Sponsor ID
20130240
Clinicaltrials.gov ID
NCT02347865
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France

Additional Study Details

Phase
Phase 4
Product
denosumab
Type
Observational
Masking
N/A
Enrollment
777
Additional Study Details

Protocol Summary

Primary Outcome Measures

patient occurence of persistence (persistence is defined in the outcome description) at 12 months

Timeframe: 12 months

Secondary Outcome Measures

patient occurence of persistence (persistence is defined in the outcome description) at 24 months and time to non-persistence at 24 months

Timeframe: 24 months

describe the use of Prolia in routine clinical practice during approximately 30 months from the first injection

Timeframe: 30 months from first injection

patient occurence of Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs) as collected in routine clinical practice

Timeframe: 30 months or early termination

Occurrence of patient reported osteoporosis related vertebral and non vertebral fractures reported during the study

Timeframe: 30 months or early termination

Locations

Location
Status
Contact Us
Location
Amgen
Paris, France, 92200
Status
Recruiting